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Completed

NCT Number: NCT05877261

Cementless Triathlon 5YR Follow-Up

All artificial joint implants need to be solidly held (fixed) within the bone. Cementless fixation has become a popular method to achieve fixation for total knee replacements where the bone grows directly onto the implanted device instead of using bone cement. The primary purpose of this study is to assess long-term implant survivorship and clinical outcomes of a previous study cohort that received a cementless knee replacement. As this study cohort approaches 5 years post-operation, the investigators will re-examine the stability of participant implants using specialized x-rays, called "radiostereometric analysis". The study will use weight-bearing computed tomography (CT) to measure bone density and texture features and correlate that with implant stability. The investigators will collect stool samples to assess participant gut microbiomes for biomarkers of poor bone quality that could correlate to implant stability. All 33 participants from the original study cohort will be invited to participate in this study.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

London, Ontario, N6A5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Were in the originally investigated cohort
  • Had successful imaging at 1-year post-operation
  • Minimum of 5 years post-operation

Exclusion criteria

  • Pregnancy
  • Unable to follow-up

Treatment and study plan

Cementless Total Knee Replacement

Device

Artificial knee implant inserted by cementless fixation.

Primary outcomes

  1. Implant Migration (tibial component)

    Time frame: 5 year follow-up

    Implant movement will be measured with model-based Radiostereometric Analysis (RSA) by registering the location of the tibial component during supine exams. Potential tibial component migration between 1 and 5 years post-operation will be measured in millimeters with the use of tibial bone markers.

Secondary outcomes

  1. Implant Migration (femoral component)

    Time frame: 5 year follow-up

    Implant movement will be measured with model-based Radiostereometric Analysis (RSA) by registering the location of the femoral component during supine exams. Potential femoral component migration between 1 and 5 years post-operation will be measured in millimeters with the use of femoral bone markers.

  2. Inducible Displacement (RSA-based)

    Time frame: 5 year follow-up

    Model-based Radiostereometric Analysis (RSA) will be used to register the location of the tibial and femoral components during supine and standing exams. Change in implant position will be measured in millimeters as maximum total point motion (MTPM) between the standing and supine RSA exams.

  3. Inducible Displacement (CT-based)

    Time frame: 5 year follow-up

    Weight-bearing computed tomography (CT) will be used to register the location of the tibial and femoral components during seated and standing exams. Change in implant position will be measured in millimeters as maximum total point motion (MTPM) between the seated and standing CT exams.

  4. Bone Density

    Time frame: 5 year follow-up

    Weight-bearing computed tomography (CT) scans will be used to measure bone density as Hounsfield units in standardized volumes of interest below the pegs and keel of the tibial component.

  5. Texture Features

    Time frame: 5 year follow-up

    Weight-bearing computed tomography (CT) texture analysis will be performed in standardized volumes of interest below the pegs and keel of the tibial component.

  6. Microbial Diversity

    Time frame: 5 year follow-up

    Participants will provide a stool sample. Microbial DNA will be extracted from the stool samples for 16s rRNA sequencing. Taxonomy will be assigned and functional annotation will be determined.

Other outcomes

  1. 12-Item Short Form Survey (SF-12)

    Time frame: 5 year follow-up

    Patient reported outcome measure observing physical and mental health status of patient. There are 12 questions asking about health (excellent to poor), activity limitations (yes, limited a lot to no, not limited at all), problems with daily activities from physical or emotional health (yes or no), pain interfering with normal work (not at all to extremely), recent positive or negative feelings (all of the time to none of the time), and interference of physical or emotional problems with social activities (all of the time to none of the time). A higher score indicates better physical and mental health function.

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 5 year follow-up

    Patient reported outcome measure observing physical symptoms following recent knee replacement surgery. Contains 24 questions asking about the amount of pain, stiffness, and activity difficulty (none to extreme). A higher score indicates greater pain, stiffness, and activity difficulty.

  3. Knee Society Score (KSS)

    Time frame: 5 year follow-up

    Patient reported outcome measure. Contains 5 sections measuring patient symptoms (none to severe), satisfaction (very satisfied to very dissatisfied), expectation (too high to too low), functional activities, and discretionary knee activities. Functional activities are split into walking and standing (with or without aids and the duration), standard activities (no bother to cannot do), and advanced activities (no bother to cannot do). Discretionary knee activities measure difficulty with the three most important activities for the patient (no bother to cannot do). Higher scores indicate greater patient outcomes.

  4. UCLA Activity Score

    Time frame: 5 year follow-up

    Patient reported outcome measure observing activity level of patient. Contains a 10-level scale with 1 representing a patient who is inactive and dependent on others, to 10 representing a patient who regularly participates in impact sports. A higher score indicates a greater activity level.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Schulich School of Medicine and Dentistry

Registry information

Official study title

5 Year Follow-Up of Migration of a Cementless Total Knee Replacement

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 26, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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